Effective Laboratory Protocols and Practices for Scientific Studies
Enhance your understanding of laboratory protocols and good practices with this comprehensive guide. Learn about the types of rules, protocol functions, and GLP requirements essential for successful scientific studies. Explore the key elements of study plans, responsibilities, resource needs, and regulatory discussions to ensure quality research outcomes.
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Presentation Transcript
GOOD LABORATORY PRACTICES STUDY PROTOCOLS (PART 1) Supplemental materials for Good Laboratory Management Training Manual for Trainers Prepared by Richard Fethiere, University of Florida FEED THE FUTURE INNOVATION LAB FOR LIVESTOCK SYSTEMS Photo Credit Goes Here
Types of rules Background Protocol / Study plan
TYPES OF RULES Instructions Established by internationally recognized scientific experts Define what should be included in studies
TYPES OF RULES Protocol / Study plan Approved by the study director May follow guidelines Description of major events in study Provides overall timelines MASTER PLAN
TYPES OF RULES Protocol / Study plan Pivotal Document: For communication to study staff To fix study objectives For contractual reasons (e.g., between contract laboratory and sponsor) To provide basic dates (to start and finish the study) To indicate study methods
GOOD LABORATORY PRACTICES Protocol / Study plan Guidelines provide information on the Content scientific methods which are recommended for specific studies Scientific They define the scientific methods which Organizational & GLP are recommended for certain studies
PROTOCOL/STUDY PLAN Functions Specify study activities (which activities and when) Define responsibilities The protocol is the pivotal scientific Define resource needs document for GLP studies Communication and instructions Basis for contracts Basis for regulatory discussions
PROTOCOL/STUDY PLAN GLP Requirements Identification Must be unique to each study Used to identify study data Must identify test compound May identify concerned department Can be cross reference to other studies
PROTOCOL/STUDY PLAN GLP Requirements Title & statement of purpose Why the study is being performed Regulatory considerations (if any) Reference to guidelines (if any) Title usually contains information on, at least, species, duration, test article & route of administration route
PROTOCOL/STUDY PLAN GLP Requirements Test and control item description typically include: Chemical name (of fertilizer, forage, grass, etc.) Batch ID Specifications
PROTOCOL/STUDY PLAN GLP Requirements Test facility/sponsor: GLP requires you to identify all the Addresses partners participating in the study Study locations (could be a multi-site study) In some multi-site studies, there can be many such partners Use of consultants Use of sub-contractors
PROTOCOL/STUDY PLAN GLP Requirements Study director & responsible personnel Must identify study director Must identify principal investigators for multi-site studies May identify other responsible researchers May identify the study monitor if one is appointed
PROTOCOL/STUDY PLAN GLP Requirements Dates Proposed experimental start and finish dates Date protocol approved by study director Date signed by management if necessary Date signed by sponsor if necessary
PROTOCOL/STUDY PLAN GLP Requirements Dates Proposed experimental start and finish dates Date protocol approved by study director Date signed by management if necessary Date signed by sponsor if necessary
Consult the Good Laboratory Management Training Manual for Trainers https://livestocklab.ifas.ufl.edu/resources/glp/ Direct link to manual in PDF: https://livestocklab.ifas.ufl.edu/media/livestocklabifasufledu/pdf- /MANUAL-Fethiere_UF_Good-lab-management-practices_2022.pdf
Feed the Future Innovation Lab for Livestock Systems https://livestocklab.ifas.ufl.edu/ https://livestocklab.ifas.ufl.edu/ (Subscribe to newsletter) livestock-lab@ufl.edu livestock-lab@ufl.edu Disclaimer This work was funded by the United States Agency for International Development (USAID) Bureau for Food Security under Agreement #AID-OAA-L-15-00003 as part of Feed the Future Innovation Lab for Livestock Systems, and by the Bill & Melinda Gates Foundation OPP#1175487. Any opinions, findings, conclusions, or recommendations expressed here are those of the authors alone.
